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Intercept signs CRADA with NIDDK for study of obeticholic acid in nonalcoholic steatohepatitis

Intercept Pharmaceuticals, Inc., a clinical stage biopharmaceutical company developing novel therapeutics for chronic fibrotic and metabolic diseases, today announced the signing of a cooperative research and development agreement (CRADA) with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health to conduct a double blind, multi-center, study to evaluate the effects of obeticholic acid in patients with nonalcoholic steatohepatitis (NASH).

28 Jul 2010

Kyowa Hakko Kirin initiates Phase 2 trial of ARQ 197 for gastric cancer: ArQule

ArQule, Inc. today announced the initiation of a Phase 2, single agent trial with ARQ 197 in gastric cancer by Kyowa Hakko Kirin, its exclusive licensee for the development and commercialization of ARQ 197 in the Asian territory consisting of Japan, China (including Hong Kong), South Korea and Taiwan. Initiation of this trial will trigger a $5 million milestone payment to ArQule from Kyowa Hakko Kirin.

28 Jul 2010

Allos reports topline results from Phase 2b trial of FOLOTYN vs erlotinib in advanced NSCLC

Allos Therapeutics, Inc. today announced topline results from the Company's randomized Phase 2b investigational trial of FOLOTYN® (pralatrexate injection) versus erlotinib in patients with Stage IIIB/IV (advanced) non-small cell lung cancer (NSCLC) who had received one or two prior systemic treatments including at least one prior platinum-based regimen. The objective of the trial was to estimate the efficacy of FOLOTYN compared to that of erlotinib as assessed by overall survival.

28 Jul 2010

Allos reports net loss of $20.0 million for second-quarter 2010

Allos Therapeutics, Inc. today reported its financial results and business highlights for the quarter and six months ended June 30, 2010.

28 Jul 2010

Pharmasset announces data from PSI-352938 single ascending dose study

Pharmasset, Inc. announced today that safety and pharmacokinetic data from the PSI-352938 single ascending dose study support progression to a multiple ascending dose trial with PSI-938, which has initiated dosing. PSI-938 is a guanine nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C virus infection.

28 Jul 2010

BiondVax receives 2010 European Influenza Vaccines Technology Innovation Award

Frost & Sullivan is pleased to announce the award of its prestigious 2010 European Influenza Vaccines Technology Innovation Award to BiondVax Pharmaceuticals for their breakthrough work on a universal influenza vaccine. This vaccine, the Multimeric-001, is designed to provide multi-season and multi-strain protection against most influenza virus strains, including both seasonal and pandemic strains, and has the potential to eliminate the need for annual flu vaccination. BiondVax is entering Phase II clinical trials for the development of the Multimeric-001 universal influenza vaccine.

28 Jul 2010

Regeneron second-quarter total revenues increase to $115.9 million

Regeneron Pharmaceuticals, Inc. announced financial and operating results for the second quarter of 2010. The Company reported a net loss of $25.5 million, or $0.31 per share (basic and diluted), for the second quarter of 2010 compared with a net loss of $14.9 million, or $0.19 per share (basic and diluted), for the second quarter of 2009.

28 Jul 2010

GSK awards NCCN $4 million grant for study of ofatumumab and pazopanib

The National Comprehensive Cancer Network has been awarded two individual $2 million grants from GlaxoSmithKline to support clinical studies of ofatumumab (Arzerra®, GlaxoSmithKline) in the treatment of hematologic malignancies and pazopanib (Votrient®, GlaxoSmithKline) in the treatment of solid tumors.

28 Jul 2010

Antares Pharma reports positive results from Anturol Gel Phase 3 study in overactive bladder patients

Antares Pharma, Inc. announced today positive results from its Phase 3 study of Anturol Gel in patients with overactive bladder. The study met its primary endpoint of a statistically significant reduction in urinary incontinence episodes for both doses studied.

28 Jul 2010

InterMune second-quarter total revenue decreases to $5.9 million

InterMune, Inc. today announced results from operations for the second quarter and six months ended June 30, 2010. InterMune also highlighted its recent clinical development and business activities, and provided forward-looking financial guidance for 2010.

28 Jul 2010

MabCure's MAbs 94% accurate in identifying ovarian cancer

Biotechnology company MabCure, Inc. today announced that a confirmatory study demonstrated the company's proprietary monoclonal antibodies (MAbs) successfully identified ovarian cancer in blood (94 percent accuracy) and with no false positives or cross-reactions with benign ovarian tumors or healthy blood. MabCure's serum diagnostic test is the first to recognize unique tumor markers or cancer fingerprints present only in ovarian cancer, the deadliest of all gynecological cancers.

28 Jul 2010

Omeros initiates enrollment in OMS302 Phase 2b clinical trial in patients undergoing cataract surgery

Omeros Corporation, a biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation and disorders of the central nervous system, today announced that it has enrolled the first patient in its Phase 2b clinical trial evaluating OMS302 in patients undergoing cataract surgery.

27 Jul 2010

Iverson Genetic Diagnostics receives CMS approval for Warfarin clinical study

Iverson Genetic Diagnostics today announced the company has received approval from CMS to conduct a WARFARIN Clinical Study. The two-year (2) study will assess the impact of genetic information in calculating doses and the changes in the rate of adverse events when initiating Warfarin drug therapy. These changes will be compared against doses initiated without genetic data. The randomized and blinded, multi-center study will involve more than 7000 participants at over 50 sites nationwide.

27 Jul 2010

Study on interactions between new antitubercular drug candidates SQ109 and TMC207

Sequella, Inc., a clinical-stage biopharmaceutical company developing drugs for treatment of life-threatening infectious diseases, announced today the publication of studies in the scientific journal Antimicrobial Agents and Chemotherapy on synergy between SQ109, its lead drug candidate for the treatment of TB, and TMC207, Tibotec lead TB drug candidate:

27 Jul 2010

Idenix second-quarter total revenues decrease to $1.3 million

Idenix Pharmaceuticals, Inc., a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today reported unaudited financial results for the second quarter and six months ended June 30, 2010. At June 30, 2010, Idenix's cash and cash equivalents totaled $51.0 million.

27 Jul 2010

QRxPharma reports positive outcome of European Scientific Advice meetings on MoxDuo IR pain therapy

QRxPharmareported today positive outcomes of its European Scientific Advice meetings on the development and registration of MoxDuo IR, an immediate release Dual-Opioid™ pain therapy. The Company is currently completing pivotal Phase 3 trials required for filing a New Drug Application (NDA) for MoxDuo IR with the United States Food and Drug Administration (FDA).

26 Jul 2010

Seaside Therapeutics reports positive data from STX209 Phase 2 study in fragile X syndrome

Seaside Therapeutics, Inc. announced today data from the largest randomized, placebo-controlled study conducted to date in individuals with fragile X syndrome. In a Phase 2 study of STX209, clinically meaningful improvements on global and specific neurobehavioral outcomes were observed in the general study population. The improvements were statistically significant in pediatric patients with more severe impairments in sociability -- a core symptom of fragile X syndrome.

26 Jul 2010

Can-Fite's CF102 decreases HCV viral load in liver cancer patients

Can-Fite BioPharma Ltd, a biotechnology company traded on the Tel Aviv Stock Exchange reported today that a significant decrease in HCV viral load was detected in 3 patients with liver cancer who are treated daily orally with CF102. The company is studying CF102 as a treatment for liver cancer (hepatocellular carcinoma, or HCC). The results announced today relate to data which came out of a Phase 1/2 clinical trial of CF102 in the treatment of patients with advanced HCC.

26 Jul 2010

Hospira commences EPO Phase I U.S. clinical trial in renal dysfunction patients with anemia

Hospira, Inc., the world leader in generic injectable pharmaceuticals, today announced the start of a U.S. Phase I clinical trial of its biosimilar erythropoietin (EPO) in patients with renal (kidney) dysfunction who have anemia, an important step on the road toward introducing a biosimilar product in the United States. Erythropoietin is a treatment for anemia associated with chronic renal failure and chemotherapy.

26 Jul 2010

AVEO's initiation of AV-299 Phase 2 trial for lung cancer triggers $750,000 milestone payment to XOMA

XOMA Ltd., a leader in the discovery and development of therapeutic antibodies, announced receipt of a $750,000 milestone payment under its collaboration with AVEO Pharmaceuticals, Inc.. The milestone payment resulted from AVEO's recent initiation of a Phase 2 clinical trial to evaluate its AV-299 antibody for the treatment of non-small cell lung cancer. AV-299 is a humanized antibody to hepatocyte growth factor (HGF).

26 Jul 2010

Drug Trial News

Intercept signs CRADA with NIDDK for study of obeticholic acid in nonalcoholic steatohepatitis

Kyowa Hakko Kirin initiates Phase 2 trial of ARQ 197 for gastric cancer: ArQule

Allos reports topline results from Phase 2b trial of FOLOTYN vs erlotinib in advanced NSCLC

Allos reports net loss of $20.0 million for second-quarter 2010

Pharmasset announces data from PSI-352938 single ascending dose study

BiondVax receives 2010 European Influenza Vaccines Technology Innovation Award

Regeneron second-quarter total revenues increase to $115.9 million

GSK awards NCCN $4 million grant for study of ofatumumab and pazopanib

Antares Pharma reports positive results from Anturol Gel Phase 3 study in overactive bladder patients

InterMune second-quarter total revenue decreases to $5.9 million

MabCure's MAbs 94% accurate in identifying ovarian cancer

Omeros initiates enrollment in OMS302 Phase 2b clinical trial in patients undergoing cataract surgery

Iverson Genetic Diagnostics receives CMS approval for Warfarin clinical study

Study on interactions between new antitubercular drug candidates SQ109 and TMC207

Idenix second-quarter total revenues decrease to $1.3 million

QRxPharma reports positive outcome of European Scientific Advice meetings on MoxDuo IR pain therapy

Seaside Therapeutics reports positive data from STX209 Phase 2 study in fragile X syndrome

Can-Fite's CF102 decreases HCV viral load in liver cancer patients

Hospira commences EPO Phase I U.S. clinical trial in renal dysfunction patients with anemia

AVEO's initiation of AV-299 Phase 2 trial for lung cancer triggers $750,000 milestone payment to XOMA

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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